Thailand's Ministry of Health issued a notice affecting medical device manufacturing and marketing authorization on June 20, 2024, and the contents are as follows.
1. Manufacturing Controllers
All establishments, license holders, or notified entities must appoint at least one manufacturing controller with the following qualifications and duties
< Qualifications and Duties >
- A bachelor’s degree or higher in Science, Pharmacy, Medicine, Engineering, Medical Technology, Veterinary Medicine, or other related scientific fields; or
- A bachelor’s degree in any field with at least one year of experience in quality management systems for medical devices.
- Must reside in Thailand.
The duties of Manufacturing Controllers include overseeing production or sales to ensure compliance with the manufacturing quality system, supervising production batches to meet legal standards and verifying control records, ensuring labels or Instructions for Use (IFU) are accurate and comply with Section 44 and Section 45 of the Medical Device Act B.E. 2551, and performing any additional duties assigned by the establishment.
2. Import Controller
< Qualifications and Duties >
- Must hold a bachelor’s degree and reside in Thailand.
- Control the import and sale process to ensure compliance with the quality system for importing and selling medical devices.
- Ensure labels or IFU are accurate and comply with Section 44 and Section 45 of the Medical Device Act B.E. 2551.
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